Kemwell's Bangalore Facility Successfully Passes EMA Renewal Audit
Kemwell Biopharma, a global contract development and manufacturing services provider, announced that the Federal Agency for Medicines and Health Products, Belgium and the Medical Products Agency (MPA), Sweden have successfully completed a cGMP joint audit of its oral solids manufacturing facility in Bangalore, India and have provided the Certificate of GMP Compliance of a Manufacturer, valid for three years. The Certificate is accepted by all health authorities in the European Union (EU) under the EU's centralized marketing authorization procedure and by authorities of several other countries that recognize EU Certification. The audit was performed as part of the European Medicines Agency's (EMA) evaluation of the Marketing Authorization Application for a NCE product for a top ten global pharmaceutical company and as a scheduled renewal audit.
Kemwell’s oral solids facility has a capacity to supply over 4 billion tablets and capsules annually and is currently shipping products to many global markets including Europe, USA, Canada, UK, Australia and South Africa.
According to Anurag Bagaria, Chairman and Managing Director, “Kemwell understands the need to maintain high quality standards and to deliver products to our customers on-time. Through an unwavering commitment to continuous improvement, we supply products to over 80 countries worldwide with an assured level of quality and value. This positive audit underscores the high standards Kemwell upholds in contract manufacturing of products for commercial use and for
products under development in compliance with rigorous international standards.”
Kemwell provides customized product development and manufacturing solutions to pharmaceutical and biopharmaceutical organizations worldwide from its facilities in India, USA and Sweden. As a 100% contract services provider, Kemwell services over 100 global bio/ pharmaceutical companies, including 7 of the top 10 Big Pharma. Founded in 1980, Kemwell employs over 1200 people, has 10 facilities worldwide and supplies to 80 countries globally.